A QA Manager is required to join a leading Pharmaceutical company based in North Dublin. This position offers an impressive and unique opportunity for interested candidates and requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This role will be responsible for providing compliance leadership ensuring the site operates to the applicable cGMP and international standards for their customers on a daily basis, as well as a number of critical responsibilities across the site. This is a great opportunity to join a select team that has quickly established itself leading the way in the Pharmaceutical industry in Ireland.

Reporting Structure - Quality Director

Key Responsibilities

Manage quality aspects of GMP computerized systems and the supporting infrastructure used on site to ensure compliance with company policies, procedures and regulatory expectations.

Mentor and coach a highly skilled, professional team to ensure that validation activities are completed in line with cGMP and international standards.

Review and approve the GMP design aspects of major capital projects including new facility construction, facilities upgrade, new manufacturing equipment and support systems.

Ensure that all Equipment and Computer Systems are validated to the required cGMP standards and are maintained in a validated status.

Coordinate and participate in review and approval of change controls, SOPs, reports and other documentation, review and approval of master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

Support customer and regulatory inspections

Drive the development and implementation of new techniques, systems and initiatives to enhance the quality system on site. Champion continuous improvement with particular focus on right first time and lean methodologies

Develop and deliver training with regard to compliance based on business needs.

Manage key elements of the quality management system including document management process, internal audit process and change control process

Partner with QA Operations team to ensure that in promoting a culture of Compliance, Right First Time and Continuous Improvement.

Education

A minimum of a Bachelor's Degree in Science, Engineering or similar technical discipline.

Advanced qualifications are desirable and at least 10 years' experience in the Pharmaceutical industry.

Core Competencies

Strong Quality and People Management skills

Strong understanding of the key business drivers of the industry/organization.

Excellent communication and organisational skills with demonstrated expertise in effectively communicating with all levels of the organisation are required.

Candidates should be able to demonstrate an ability to lead cross-functional teams and to make decisions in pressurised situations to ensure compliance.

Interested?For more information on this, and other suitable roles, please contact Jack on 01-6455250, or email your CV to jack.conway-kenny AT experis.ie